Hsu 2008.
Methods | This was a randomised, double‐blind, placebo‐controlled clinical trial with a randomisation ratio of 1:1 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
|
|
Interventions |
NUMBER OF STUDY CENTRES: 1 COUNTRY/ LOCATION: Taiwan/Taipei SETTING: hospital (outpatient clinic) TREATMENT BEFORE STUDY: note: in the lead‐in period of 2 weeks, the patients should maintain weight and weight control within 0.5% |
|
Outcomes |
OUTCOME(S) (as stated in the protocol/registered trial documents): PRIMARY OUTCOME(S): per cent reduction of BMI and body weight SECONDARY OUTCOME(S): per cent reduction of: glucose, cholesterol, LDL, HDL and triglycerides, leptin, adiponectin and ghrelin comparisons and analysis OTHER OUTCOME(S): NR |
|
Study details | STUDY TERMINATED BEFORE REGULAR END: no | |
Publication details | This study was published in English in Clinical Nutrition, a peer‐reviewed journal, and was supported by a grant from the National Science Council, Taiwan | |
Stated aim of study | Quote from study: "thus, we conducted this randomised clinical trial to examine the effect of GTE [green tea extract] on obese women and to explore the relationship between GTE and obesity‐related hormone peptides." | |
Notes | Our inclusion criteria state that we will only look at studies with participants over the age of 18. In this case, we contacted the author and learned that though the researchers would have accepted participants below the age of 18, no such participants were included in this study. BMI: body mass index; HDL: high‐density lipoprotein; LDL: low‐density lipoprotein; NR: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from study: "a random number between 0.0 and 0.99 was generated by the computer for each subject. Subjects with a random number between 0.0 and 0.49 were assigned to the group with the GTE [green tea extract] while those with a random number between 0.50 and 0.99 were assigned to the placebo group with cellulose" Comment: sequence generation was appropriate |
Allocation concealment (selection bias) | Low risk | Comment: numbers were computer generated as each patient was enrolled therefore the group they would be allocated to was concealed and depended upon the computer to generate |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from study: "a randomised, double‐blind, placebo‐controlled clinical trial was conducted" "The same opaque capsules containing either dried powder GTE or placebo (cellulose) were administered to the subjects by a research assistant blinded to the contents in the capsules. All subjects were treated in the same fashion" Comment: no mention of effectiveness of blinding efforts; however, care was clearly taken to blind both staff and participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: all outcomes on which the study reported were objective and measured by assessors. Therefore, whether or not assessors were blinded, risk of detection bias was assessed as low |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: study authors gave reasons that most but not all participants withdrew from the study. The number who did not complete the study was higher than for other studies: 9/50 in the intervention and 13/50 in the controlled group. It is unclear the effect that those who did not give reasons for withdrawal and those who withdrew because they did not see an effect may have had on results |
Selective reporting (reporting bias) | Low risk | Comment: outcomes specified at the beginning were adequately investigated and reported |
Other bias | Low risk | Comment: appears to be free of other bias |